AVAXIM® is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above.1
Summary
Seroprotection achieved after 14 days, shorter than the incubation period of the disease meaning that vaccination on the day of departure may still protect from disease clinical manifestation.*1,2
Higher immune response was observed 1 month after booster dose with Avaxim vs Havrix.†3
Higher immune response among subjects who were seronegative at study entry at both 1 month and 24 months after the primary dose of Avaxim vs Vaqta.††4
Seroprotection achieved after 14 days, shorter than the incubation period of the disease meaning that vaccination on the day of departure may still protect from disease clinical manifestation.*1,2
Higher immune response was observed 1 month after booster dose with Avaxim vs Havrix.†3
Higher immune response among subjects who were seronegative at study entry at both 1 month and 24 months after the primary dose of Avaxim vs Vaqta.††4
*Studies suggest that the hepatitis A virus has a minimum incubation period of 15 days, and an average of 28 days. Avaxim may be administered on the day of departure and may still protect from disease clinical manifestation as 90% of immunocompetent patients reach protective levels as early as Day 14.
† Randomised, single-blind trial comparing Avaxim (n=92) and Havrix (n=93). One hundred and eighty-five subjects were randomised 6 to 7 months after a primary dose of Havrix. Serology samples for HAV antibody titers were taken at 28 ±7 days after visit 1. Increase in GMT one month following administration in the Avaxim group was 642 mlU/mL to 6669 mlU/mL compared to 739 mlU/mLto 4460 mlU/mL in the Havrix group (p=0.02).3
†† Open-label, randomised study comparing Avaxim (n=172) and Vaqta (n=173). Rates of seropositivity (>10mIU of specific anti-HA antibody) 1 month after the primary dose were 74/74 (100%) in the Avaxim group and 60/66 (90.9%), in the Vaqta group (p=0.01). Rates of seropositivity 24 months after the primary dose were 65/69 (94.2%) in the Avaxim group and 54/61 (88.5%) in the Vaqta group (p=0.346).4
Safety Profile
AVAXIM is a generally well-tolerated vaccine against Hepatitis A.1
Significantly fewer local injection site reactions with Avaxim (0.5ml dose) compared to Havrix monodose (1.0ml dose) after both injections in initially seronegative individuals.3
| Adverse reactions | Frequency |
|---|---|
| Immune system disorders | |
| Anaphylactic reaction | Not known |
| Nervous system disorders | |
| Headache | Common |
| Vasovagal syncope in response to injection | Not known |
| Gastrointestinal disorders | |
| Nausea | Common |
| Vomiting | Common |
| Decreased appetite | Common |
| Diarrhoea | Common |
| Abdominal pain | Common |
| Skin and subcutaneous tissue disorders | |
| Urticaria | Not known |
| Rashes associated or not with pruritus | Not known |
| Musculoskeletal and connective tissue disorders | |
| Myalgia | Common |
| Arthralgia | Common |
| General disorders and administration site conditions | |
| Asthenia | Very common |
| Mild fever | Common |
| Mild injection site pain | Very common |
| Injection site erythema | Uncommon |
| Injection site nodule | Rare |
| Investigations | |
| Transaminases increased (mild and reversible) | Rare |
AVAXIM is a generally well-tolerated vaccine against Hepatitis A.1
Significantly fewer local injection site reactions with Avaxim (0.5ml dose) compared to Havrix monodose (1.0ml dose) after both injections in initially seronegative individuals.3
| Adverse reactions | Frequency |
|---|---|
| Immune system disorders | |
| Anaphylactic reaction | Not known |
| Nervous system disorders | |
| Headache | Common |
| Vasovagal syncope in response to injection | Not known |
| Gastrointestinal disorders | |
| Nausea | Common |
| Vomiting | Common |
| Decreased appetite | Common |
| Diarrhoea | Common |
| Abdominal pain | Common |
| Skin and subcutaneous tissue disorders | |
| Urticaria | Not known |
| Rashes associated or not with pruritus | Not known |
| Musculoskeletal and connective tissue disorders | |
| Myalgia | Common |
| Arthralgia | Common |
| General disorders and administration site conditions | |
| Asthenia | Very common |
| Mild fever | Common |
| Mild injection site pain | Very common |
| Injection site erythema | Uncommon |
| Injection site nodule | Rare |
| Investigations | |
| Transaminases increased (mild and reversible) | Rare |
.
References
- Avaxim Summary of Product Characteristics
- Connor BA. Am J Med 2005; 118: 58-62
- Zuckerman JN, Kirkpatrick CT, Huang M. J Travel Med 1998; 5:18-22
- Orr N et al. Vaccine 2006; 24: 4328-32
MAT-XU-2502372 (v2.0) Date of preparation: August 2025